February 16th – 20th 2026

Inform Items

1. The guidance for Surgical Loan Kits has been published on the TGA website – Manufacturing and supplying surgical loan kits to Australian hospitals | Therapeutic Goods Administration (TGA).
2. The NHMRC has endorsed CT:IQ’s InFORMed Participant Information and Consent Form (PICF) template, aimed at making clinical trial consent forms clearer and easier for participants to understand. Existing PICF templates, often exceeding 25 pages, have been criticised for being overly complex and legalistic, making it difficult for patients to make informed decisions during already stressful situations. The InFORMed template was developed through a national, consultative process involving researchers, ethics bodies, and consumers, with the goal of improving clarity while maintaining regulatory and ethical requirements. The new template and supporting resources are now available to support more participant-centred clinical research across Australia.
3. This week, the TGA has released updates to several UDI related products:

• UDI Guidance (Complying with the Unique Device Identification requirements for medical devices | Therapeutic Goods Administration (TGA)) – the UDI Guidance has been updated based on sponsor feedback on requirements and document content and usability. Many of these comments were raised during the 2025 UDI Roadshows.
• Australian UDI Database (AusUDID) – the AusUDID was updated on 19 February with improvements to usability and system performance and security. The HL7 SPL and NPC interfaces were updated with version V1.4 of the M2M HL7 SPL Documentation Suite was published on the UDI Hub (M2M HL7 SPL Documentation Suite V1.4). Detailed information on the release is in the Australian UDI Database Production environment: Release notes | Therapeutic Goods Administration (TGA)
• The AusUDID Grace Period in the AusUDID Production environment was extended from 7 days to 30 days, allowing sponsors and manufacturers additional time to correct any errors that may be found in the early stages of the AusUDID data loading.

Action Items

1. We are inviting nominations to MTAA’s 2026 Clinical Investigations Forum (CIF), please reach out to LAW or JB if you or someone in your organisation would like to be involved.
2. There are two open consultations:

i) Conformity Assessment Procedures – please reach out to LAW if you would like to be in the consultation working group. Once the feedback excel sheet is populated, we intend to approach the TGA for a dialogue on the same. The deadline for our response is March 31st.

ii) TGA Fees and Charges – feedback on TGA’s proposed fees and charges for 2026-27. Attached is the draft of our response.